The US Food and Drug Administration (FDA) has approved Boston Scientific鈥檚 expanded instructions for use (IFU) labelling of the Farapulse pulsed field ablation (PFA) system.
The approval marks a development in the treatment of drug-refractory, symptomatic persistent atrial fibrillation (AF), a condition where the heart beats irregularly for at least seven days.
The Farapulse PFA system, which delivers pulsed field energy through a catheter to ablate the tissue of the heart, has had its IFU updated for the Farawave PFA and Farawave NAV PFA catheters.
Boston Scientific AF Solutions chief medical officer Brad Sutton said: 鈥淲e look forward to studying the system in new clinical trials, including patients in need of re-do ablations and those with more complex arrhythmias, which account for a large portion of the procedures today still using thermal ablation.鈥�
The agency鈥檚 decision to approve the expanded labelling was based on clinical evidence from Phase I of the ADVANTAGE AF trial. The findings, showcased at the AF Symposium 2025 and published in the Journal of the American College of Cardiology, satisfied both primary safety and effectiveness endpoints.
The trial involved 260 subjects at 43 sites worldwide, all intolerant to a minimum of one Class I/III anti-arrhythmic drug (AAD).
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By GlobalDataThe study notably reported no incidences of stroke, atrial-oesophageal fistula, pulmonary vein stenosis, or major access complications.
Moreover, the symptomatic AF recurrence-free rate stood at 85.3%. This rate increased to 91.4% among physicians who performed at least three procedures.
Looking ahead, the company is poised to receive the CE mark and approvals in China and Japan.
The company has recently initiated the ReMATCH IDE trial, set to involve around 375 subjects across 40 centres in Asia and the US.
In April 2025, Boston Scientific reported positive one-year primary endpoint outcomes from Phase II of the ADVANTAGE AF trial. This phase evaluated the Farapulse PFA system and Farapoint PFA Catheter as adjunctive treatments for persistent AF.
